Spinal Ropivacaine for Cesarean Delivery: A Comparison of Commonly Hyperbaric and Marginally Hyperbaric Solutions
Description:
INTRODUCTION:
One previous study has confirmed that the marginally hyperbaric solutions of bupivacaine can
maintain good quality of anesthesia and get a more steadily hemodynamic status than commonly
hyperbaric solutions, some authors confirmed the plain ropivacaine for cesarean section have
a higher failure rate and commonly hyperbaric solutions of ropivacaine have a higher
incidence of side reaction such as hypotension. It is unclear what the efficacy of spinal
marginally hyperbaric ropivacaine for elective cesarean delivery.The investigator of this
study hypothesized that the marginally hyperbaric ropivacaine would get a similar efficacy to
commonly hyperbaric solutions but a more steadily hemodynamic status.In this prospective,
randomized, double-blinded study, Investigator will compare the clinical efficacy and adverse
effect of spinal anesthesia with commonly hyperbaric and marginally hyperbaric ropivacaine
for elective cesarean delivery.
Ethical approval for this clinical trial (Ethical Committee No.) was provided by the Ethics
Committee of Qilu Hospital of Shandong University (Qingdao), Qingdao, China on 1 February
2016. Informed written consent will be obtained from all patients. Investigator expected to
recruit 120 Pregnant women who will scheduled for elective cesarean section and meet the
inclusion criteria.
A computer-generated random number sequence will be used for group allocation. To ensure the
study will be double blinded, the anesthesiologist who will administer the anesthesia will
take no other part in the study, whilst another anesthesiologist blind to the allocation will
collected intraoperative and postoperative data. The patients would be unaware of the
treatment allocation. Women will be randomised into two groups: the commonly hyperbaric group
(CH) will receive ropivacaine solution with 8.3% glucose; group marginally hyperbaric group
(MH) will receive ropivacaine solution with 0.83% glucose; Density will be determined by
using a digital density meter (DMA4500M; Anton Paar GmbH, Graz, Austria) at 37°C.Fifteen
minutes prior to administration of anesthesia, the ropivacaine solution will be prepared by
one nurse who is blind to the patient allocation.Commomly hyperbaric ropivacaine solutions
will be made of 0.75% ropivacaine + 50% glucose + isotonic saline and Marginally hyperbaric
solutions will be made of 0.75% ropivacaine +5% glucose + isotonic saline. The doses of
ropivacaine and the volume of spinal solution will be same and only the density of the
solution will be different.
When the patient arrived at the operating room, an IV cannula will be inserted in one
forearm. Standard monitoring with electrocardiography and pulse oximetry and cerebral oxygen
saturation(ScO2) and invasive blood pressure (IBP) will be attached.
During the operation, the room temperature will be kept at 24°C. The body temperature of each
patient will be maintained by an electric warming blanket and infusion heating device.
The data of systolic pressure and ScO2 wil be recorded at 5-6 second intervals on the
device’s accessory disk drive for later analysis. To establish a baseline for blood pressure
and ScO2. No prehydration will be given. Lactated Ringers’ solution at 0.4 ml kg-1 min-1 will
be infused after anesthesia. Supplemental oxygen is planned to be administered in case SpO2
values would be below 91%.
The combined spinal-epidural anesthesia (CSEA) would be performed in the lateral position at
the intervertebral space between L3 and L4. Then, spinal solution will be injected
intrathecalley after CSF releas. The epidural catheter will be inserted. The patient will be
immediately placed in a supine position with 15° left tilt. Completion of the spinal
injection would be considered as time zero. The sensory block will be determined by pinprick
along both sides of the midclavicular line at 2 min intervals post injection. The sensory
block had not reached T8 before surgery, or there was moderate pain during the skin incision,
spinal anesthesia would be considered to have failed.
The efficacy of anesthesia would be evaluated using three criteria: lower limb motor block,
muscle relaxation and pain during skin incision and abdominal exploration.
To treat intraoperative hypotension, 6mg ephedrine will be injected followed by 3 mg every 2
min until the blood pressure was restored to normal. Instances of nausea, vomiting, shivering
and pruritus will be also recorded.
After delivery, Apgar scores will be assessed at 1 and 5 min by the attending pediatrician.
On the basis of the results of a pilot study, 40 patients in each group were needed to
compare a two-segment difference in the upper sensory level and 30 % difference in the
incidence of hypotension at a significance level of P less than 0.05 with 80% power. However,
We expect to enroll 120 patients to get a more precise result.
For IBP and ScO2 the median value of the sliding averages of the 30-second period before
spinal induction will be used as the baseline value for the figures and statistical analyses.
Time 0 for hemodynamic analyses will be defined as the end of spinal injection. This two
variables analyses will be run for the first 15 minutes, which almost equaled to the interval
from induction of spinal anesthesia to delivery.
SPSS 16.0 will be used for data analysis. T-test would be used to assess the difference in
sensory block level amongst the groups, The linear mixed model to analyze the continuous
changes in systolic pressure and ScO2 over time. X2 test for trends would be used to test the
association between adverse effects of anesthesia and the groups. In all cases, a P value
less than 0.05 was considered statistically significant.
Condition:
Anesthesia, Spinal
Treatment:
hyperbaric ropivacaine
Start Date:
May 2017
Sponsor:
Qilu Hospital of Shandong University (Qingdao)
For More Information:
https://clinicaltrials.gov/show/NCT03142880